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A PATIENT EXAMINATION GLOVES IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

Classified by FDA's General and Plastic Surgery Device panel as Class 1, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-06.

The provided text describes a 510(k) premarket notification for disposable powder-free vinyl synthetic exam gloves. This is a medical device and the submission focuses on demonstrating substantial equivalence to a predicate device, not on proving effectiveness through clinical studies with specific acceptance criteria in the way a diagnostic or therapeutic AI device would.

Therefore, many of the requested points are not applicable to this type of device and submission. I will address the applicable points and note where information is not relevant to this submission.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Physical and Dimensions Testing: "Inspection level S-2, AQL 4.0." The exact sample size is not explicitly stated, but these are standard sampling plans (e.g., in accordance with ISO 2859-1 or similar). The data provenance is not specified beyond being generated by the device manufacturer, Rich Mountain Medical Products Inc.
• Watertight Test: "samplings of AQL 2.5, Inspection level 1." The exact sample size is not explicitly stated, but these are standard sampling plans. The data provenance is not specified.
• Primary Skin Irritation and Skin Sensitization: Sample size not specified.
• Residual Powder Test: Sample size not specified.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not applicable. This submission is for physical examination gloves, not an AI/ML device that requires expert-established ground truth for a test set. The tests performed are laboratory-based and involve physical properties and biocompatibility.

4. Adjudication Method for the Test Set

• Not applicable. See point 3.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Not applicable. This is not an AI/ML device, and no MRMC study was conducted.

6. Standalone (Algorithm Only) Performance Study

• Not applicable. This is not an AI/ML algorithm; it is a physical medical device.

7. Type of Ground Truth Used

• Physical and Biocompatibility Test Results: The "ground truth" for this device comes from adherence to established engineering standards (ASTM D5250-06, ASTM D-5151-06, ASTM D6124-06) and biocompatibility testing results (primary skin irritation and sensitization). These are objective measurements and assessments against predefined criteria.

8. Sample Size for the Training Set

• Not applicable. This is not an AI/ML device, and therefore does not have a "training set" in the context of machine learning. The manufacturing process is implicitly "trained" through quality control and adherence to standards, but not in the machine learning sense.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. See point 8.

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A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WHITE COLOR

The provided text is a 510(k) premarket notification letter from the FDA regarding "Disposable Powdered Free Vinyl Synthetic Exam Gloves White Color." This document primarily addresses the substantial equivalence determination for a medical device and does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications, as would typically be found in a study report or clinical trial documentation.

Therefore, I cannot provide the requested information based solely on the input provided. The document confirms the device's classification and allows its marketing but does not detail the technical performance or the studies behind it.

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A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WHITE COLOR

The provided text is a 510(k) summary letter from the FDA to Synmertex Company Limited regarding their Disposable Powder Free Vinyl Synthetic Examination Gloves. This letter does not describe acceptance criteria for a device, nor does it detail a study proving device performance based on such criteria. Instead, it is an FDA clearance letter, indicating that the device has been determined to be substantially equivalent to a legally marketed predicate device.

Therefore, I cannot provide the requested information from the given text.

The document discusses:

• Device Name: Disposable Powder Free Vinyl Synthetic Examination Gloves, White Color
• Regulation Number & Product Code: 880.6250, LYZ (Patient Examination Glove, Class I)
• Indications For Use: "A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner."
• FDA Clearance: The letter states the device is "substantially equivalent" to predicate devices.

This type of FDA letter confirms market clearance, but it does not include detailed performance studies, acceptance criteria, or ground truth methodologies that would be typical for many medical devices, especially those involving AI or more complex functionalities. For examination gloves, performance is usually assessed against established ASTM (American Society for Testing and Materials) standards (e.g., for barrier integrity, tensile strength), but these details are not present in this FDA clearance letter.

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A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WHITE COLOR

This document is a 510(k) premarket notification letter from the FDA regarding "Disposable Powder Free Vinyl Synthetic Examination Gloves, White Color." It primarily addresses the substantial equivalence determination for the device. As such, it does not contain the kind of detailed study information (acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, expert qualifications, etc.) that would be associated with a study demonstrating a device meets acceptance criteria for an AI/CAD system.

The document is for a Class I medical device (patient examination gloves), which typically has much simpler regulatory requirements than more complex devices and certainly does not involve AI or sophisticated image analysis.

Therefore, I cannot provide the requested information from the given text. The provided text does not describe a study that proves a device meets acceptance criteria in the way you've outlined for an AI/CAD system.

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DISPOSABLE PATIENT EXAMINATION GLOVES IS A DEVICE INTENDED FOR MEDICAL PURPOSES WORN ON THE EXAMINER'S HAND OR FINGER, FOR MEDICAL PURPOSES WORN ON THE EXAMINER'S HAND OR FINGER, FOR MEDICAL PURPOSES WORN ON THE BRINESE

Disposable Powder Free Vinyl Synthetic Examination Gloves, White

This FDA document, K013753, is for "Disposable Powder Free Vinyl Synthetic Examination Gloves, White". It is a 510(k) premarket notification indicating substantial equivalence to a predicate device. This type of submission, for a Class I device like examination gloves, does not typically include detailed clinical studies with specific acceptance criteria, sample sizes, or ground truth methodologies as would be found for more complex diagnostic or AI-driven medical devices.

Therefore, I cannot provide the requested information in the format of the table or answer the specific questions (2-9) because the source document does not contain this type of data.

Here's why:

• Device Type: Examination gloves are Class I devices. Their substantial equivalence is usually demonstrated through meeting recognized consensus standards for material properties, sterility (if applicable), and physical performance (e.g., tensile strength, barrier integrity).
• 510(k) Process for Class I Devices: For many Class I devices, the 510(k) submission primarily focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through bench testing and adherence to standards, rather than complex clinical trials involving patient outcomes or expert interpretations. The "performance data" for such devices would typically be laboratory test results against established ASTM or ISO standards.

If this were an AI-driven diagnostic device, the requested information would be highly relevant and often found in the 510(k) summary or associated documents. However, for a Class I examination glove, the information you're asking for isn't part of the regulatory review process in the same way.

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